I.V. Administration Set
FDA 510(k) clearance K242126 · decided 2024-08-22
Clearance details
- K-number
- K242126
- Device name
- I.V. Administration Set
- Applicant
- Bq Plus Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-19
- Decision date
- 2024-08-22
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE recall (Z-1366-2026) | Medline Industries, LP | 2026-02-13 |